The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope

NCT03962374 | Unknown

• 1 other identifier: 4-2019-0289
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effect of frova and stylet on the success rate of tracheal intubation when using a video laryngoscope.

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Success rate of first attempt of endotracheal intubation

  The endotracheal intubation will be attempted using stylet or frova according to the randomized group. The success or failure of the attempt will be recorded.

  for 10 minutes during anesthetic induction

Secondary Outcomes (1)

• time for endotracheal intubation

  for 10 minutes during anesthetic induction

Study Arms (2)

Frova

EXPERIMENTAL

Frova will be used to facilitate the endotracheal intubation.

Device: Frova

Stylet

ACTIVE COMPARATOR

Stylet will be used to facilitate the endotracheal intubation.

Device: Stylet

Interventions

Frova DEVICE

Frova will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.

Frova

Stylet DEVICE

Stylet will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.

Stylet

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. adult patients aged over 19 years who are undergoing endotracheal intubation for elective surgery.
• \. Patients who have one of the predictors of difficult intubation such as Mallampati classification 3 or 4, limited the movement of the neck, body mass index less than 35 kg/m2, a distance from the tip of the chin to the thyroid cartilage of less than 6.5 cm, a interincisor distance less than 3.5 cm, inability to protrude of lower incisors over the upper incisors, or a diagnosis of obstructive sleep apnea.

You may not qualify if:

• \. Patients receiving emergency surgery
• \. Pregnant women
• \. Patients scheduled for oral surgery such as tonsillectomy, vocal cord surgery
• \. Patients who have a history of ankylosing spondylitis or have a large tumor of 4 cm or more on the tongue and need an awake intubation
• \. Patients who are at risk of vomiting due to not fasting time

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Central Study Contacts

Hyun Joo Kim, MD, Ph.D

CONTACT

02-2224-1389; jjollong@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: June 21, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)